I. GMP Guideline for Drug Products: Text - NIHS

添 付 資 料 4 GMP Guideline for Drug Products4.16 Laboratory areas/operations should normally be separated from manufacturingareas. Some laboratory areas, in particular for in-process controls, can be locatedin manufacturing areas, provided that the operations of the manufacturing processdo not adversely affect accuracy of the inspection/testing, and the laboratory andits operations do not adversely affect manufacturing processes or products.4.17 The laboratory should be appropriately designed for the operations conducted there.Appropriate arrangement should be made such as providing sufficient space toprevent any mix-ups, contamination and cross-contamination. Sufficient andappropriate space for storage of collected samples and records should be provided.4.2 Buildings and Facilities for Utilities4.20 As to all utilities that could affect product quality (e.g., steam, gases, compressedair, etc.), appropriate monitoring should be performed to check whether theyconform to the specifications predefined to control them. Necessary actionsshould be taken when limits are exceeded.4.21 Buildings and facilities necessary for adequate ventilation, air filtration andexhaust should be provided. These buildings and facilities should be designedand constructed to minimize risks of contamination and cross-contamination andshould include equipment for control of room pressure, microorganisms, dust,humidity, and temperature, as appropriate to the stage of manufacture. Particularattention should be given to areas where products are exposed to the air inside themanufacturing site.4.22 If air is recirculated to manufacturing areas, appropriate measures should be takenon the buildings and facilities to minimize risks of contamination andcross-contamination.4.23 Permanently installed pipework should be appropriately identified. This can beaccomplished by identifying individual lines, documentation, computer controlsystems, or alternative means. Pipework should be located to avoid risks ofcontamination of products.4.24 Drains should be of adequate size and should be provided with an air break or asuitable device to prevent backward flow, when appropriate.4.3 Buildings and Facilities for Purifying Water4.30 Purifying water should be demonstrated to be suitable for its intended use. Whenany water outside the standards listed in the compendium is used, the internalstandard with valid ground should be established and documented.4.31 Unless otherwise justified, purifying water should, at a minimum, meet the waterquality standards based on Japanese Pharmacopoeia or Tap Water Law, or WorldHealth Organization (WHO) guidelines for drinking water quality.14